Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

NCT02307084 | Terminated

• 1 other identifier: CS/2014/4661
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.

Conditions

Surgical Wound Infection; Coronary Artery Bypass

Keywords

surgical site infection; long saphenous vein; coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

• Surgical site infection at the conduit harvest site

  The ASEPSIS tool is a well established tool to quantify wound healing disturbances.

  30 days of CABG surgery

Secondary Outcomes (5)

• Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.

  baseline

• Time taken to harvest a suitable conduit.

  intraoperative

• Length of lower limb vein harvest wounds.

  1 day Post-operation

• Blood loss from the vein harvest wound

  intraoperative

• Patient questionnaire to assess wound/scar satisfaction and complications.

  30 days from surgery

Study Arms (2)

Pre-operative ultrasound imaging

EXPERIMENTAL

Subjects that are randomly allocated to this group will have ultrasound imaging assessment of the long saphenous vein in both legs. This will allow assessment of the suitability of the long saphenous vein and marking of the distribution prior to heart bypass surgery to allow targeted harvesting of a bypass conduit.

Procedure: Ultrasound imaging of the long saphenous vein

Current protocol

NO INTERVENTION

This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols.

Interventions

Ultrasound imaging of the long saphenous vein PROCEDURE

Ultrasound imaging of the long saphenous vein from the ankle to the saphenofemoral junction. This will allow assessment of vein calibre, branches and bifurcations, presence of thrombophlebitis and distribution. The presence of a proximal deep vein thrombosis will also be assessed.

Pre-operative ultrasound imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for CABG surgery with long saphenous vein harvesting.
• Aged over 18 years.
• Capable of providing informed consent.
• Five days or more to consider participation prior to surgery if an outpatient or 2 days if an inpatient referred by their consultant.
• Operative procedure to be undertaken at the Bristol Heart Institute.

You may not qualify if:

• Operation within 48h hours if an inpatient or 5 days if an outpatient.
• Aged below 18 years of age.
• Incapable of providing informed consent i.e. confirmed diagnosis of dementia or other mental health conditions or unconscious.
• Current participant in a different randomised control trial.
• Pregnancy
• Active cancer
• Immunosuppressed.
• Non-English speaker that requires a Trust translator.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead

Study Sites (1)

University Hospital Bristol NHS FT

Bristol, BS2 8HW, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reshat Reshat, PhD

  University Hospital Bristol NHS FT

  PRINCIPAL INVESTIGATOR

• Teresa Robinson, MSc

  University Hospital Bristol NHS FT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: February 1, 2015
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)